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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL INC MPS 3 CONSOLE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

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QUEST MEDICAL INC MPS 3 CONSOLE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 5301000
Device Problem Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 06/06/2022
Event Type  malfunction  
Event Description
While our cardiac perfusionist was using the 'quest medical mps 3' during a procedure, the 'bubble trap' portion of the device repeatedly failed, stating that there was air in the line when there wasn't, causing there to be a delay in care to the patient.When this device detects air in the system, it diverts the blood that is infused with potassium and lidocaine and recirculates it back through the machine instead of back through the patient.This process normally takes between 1 to 2 seconds, but in this instance the machine was constantly stating that there was air in the lines when there were no obvious signs of air.With the machine incorrectly saying that there was air in the line, it constantly kept the line open that recycles the blood and medication back into the machine instead of giving it back to the patient.The alarm would not clear, even with there being no air in any lines, so the line that was open because of the false alarm had to be clamped shut to make the pump work properly.The case was finished, and the machine was taken out of service.Manufacturer response for heat-exchanger, cardiopulmonary bypass, mps 3 console (per site reporter) our bio med department has been having trouble, until recently, contacting the reps and having this issue dealt with.They told us they would replace all 3 of our machines free of charge and get us brand new machines.
 
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Brand Name
MPS 3 CONSOLE
Type of Device
HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
QUEST MEDICAL INC
1 allentown pkwy
allen TX 75002
MDR Report Key14674124
MDR Text Key293834661
Report Number14674124
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2022,06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number5301000
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2022
Event Location Hospital
Date Report to Manufacturer06/13/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/13/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27740 DA
Patient SexFemale
Patient Weight86 KG
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